Status:
RECRUITING
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Human Papillomavirus-Related Carcinoma
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
This phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus (HPV)-related cancers in women. RG1-VLP is a vaccine that aims to p...
Detailed Description
PRIMARY OBJECTIVE: I. Assess the safety of RG1-virus-like particles (VLP) in healthy 18-60 years old women at 3 escalating doses. SECONDARY OBJECTIVES: I. Determine the immunogenicity of RG1-VLP in...
Eligibility Criteria
Inclusion
- Women, age 18 - 60 years. Because no dosing or adverse event (AE) data is currently available for the use of RG1-VLP in humans, children and adolescents are excluded from this study
- White blood cell (WBC) between 3000/mm\^3 - institutional upper limit of normal
- Hemoglobin (Hgb) between 10 g/dl - institutional upper limit of normal
- Platelets \>= 100,000/mm\^3
- Serum creatinine within institutional normal limits
- Bilirubin =\< 2x institutional upper limit of normal
- Alanine aminotransferase (ALT) =\< 2x institutional upper limit of normal
- Aspartate aminotransferase (AST) =\< 2x institutional upper limit of normal
- Human immunodeficiency virus (HIV)-1/HIV-2 negative
- Hepatitis B and hepatitis C negative
- The effects of RG1-VLP vaccination on the developing human fetus at the proposed doses are unknown. For this reason, all women of childbearing potential will have a pregnancy test and all heterosexually active women must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- The following persons are not considered to be able to bear children and are therefore eligible to participate without the use of concurrent birth control:
- Female with bilateral oophorectomy and/or hysterectomy
- Female with fallopian tubes cut, tied or sealed
- Female with sterilization implant (e.g. Adiana, Essure) placed \> 3 months prior to randomization
- Female post-menopausal (\> 1 year since last menses or prior laboratory follicle stimulating hormone \[FSH\] value per institutional range indicating post-menopausal)
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- History of any of the following:
- Prior or current genital warts
- Treatment for anogenital intraepithelial neoplasia (cervical intraepithelial neoplasia \[CIN\], anal intraepithelial neoplasia \[AIN\], vaginal intraepithelial neoplasia \[VAIN\], vulvar intraepithelial neoplasia \[VIN\])
- Systemic cancer treatment within the prior year
- History of anaphylaxis to vaccines
- Any prior vaccination with Gardasil, Gardasil-9, or Cervarix or other HPV vaccine
- Receipt of blood products within 3 months of enrollment, or continuing plasma donation
- Participants receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the adjuvant or to RG1-VLP
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements or preclude protocol vaccination
- Pregnant women or actively lactating women are excluded from this study because RG1-VLP is a vaccine with the potential for teratogenic or abortifacient effects
- Planned receipt of any inactivated vaccine in the 2 weeks preceding and the 2 weeks following any trial vaccination
- Planned receipt of any live attenuated vaccine in the 4 weeks preceding and the 4 weeks following any trial vaccination
- Women with a history of bleeding disorders or use of anticoagulants (aspirin is acceptable)
- Had prior medical diagnoses:
- Rheumatoid arthritis or other auto-immune disease
- Congenital or acquired immunodeficiency
- Collagen vascular disease
- Following medical treatments:
- Current use of immunosuppressive drugs including corticosteroid use (inhaled or topical steroids are permitted)
- Unrecovered major infections and/or surgical procedures
Key Trial Info
Start Date :
February 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05985681
Start Date
February 27 2025
End Date
June 1 2027
Last Update
September 29 2025
Active Locations (5)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
3
Staten Island University Hospital
Staten Island, New York, United States, 10305
4
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792